GUEST COLUMNISTS

• AI & Intelligent Technologies: Finding The Right Fit For Your Pharma Or Medtech Company

  This article takes a closer look at AI and intelligent technologies in biotech, medical devices, and pharma, and what we can expect to tackle in 2022 and beyond. The article also identifies some of the new concerns and challenges with disruptive technologies and risk management, and discusses a technology and generation timeline.

• 4 Tips For Medical Device Design Success

  We are all eagerly anticipating what 2022 will bring us. This author found that when developing a forward vision, it always helps to look back and see what we learned in the past. He uses some personal experiences of designing surgical robotics for these 4 tips.

• Merck’s 2 Lessons Learned In Overcoming Single-Use Materials Supply Challenges

  The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

• 2021’s Bioprocessing Year In Review & 7 Key Takeaways

  The biopharma and bioprocessing industries have responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have accelerated existing trends and created the need for new strategies. These are just a few of the findings presented in BioPlan Associates’ 2021 18^th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

• Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

  This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

• Regulatory Perspectives For CGT Development: Continued Need For Standards And Perseverance

  The need for standards not only lies in the identification and development of standards, but also in implementation.

• Are You Leveraging KOLs For Biopharma Market Access As Much As You Could Be?

  Pharmaceutical companies spend a lot of time and effort engaging and collaborating with key opinion leaders (KOLs), an exercise typically owned by medical affairs. But few take advantage of network mapping tools and relationship-building principles from a market access lens to help inform and shape coverage strategies and identify access champions for their products.

• How Can We Use The UDI To Improve The Device Recall Process?

  The Unique Device Identifier (UDI) was expected to improve patient and medical device safety by enhancing key patient safety systems like the product recall and adverse event reporting processes and improving device evaluation. AHRMM recently completed a survey of various stakeholders; this article delves into the survey's findings and the recommendations for improving the device recall process.